Summary of Position
Creating and updating product information (summary of product characteristics, patient information leaflet, labeling) for marketing authorization applications or variations.
Support for new Marketing Authorisation registrations.
Preparation, submission and tracking of Product Information related variations.
Modification of Product Information (SmPC, Patient Information Leaflet, and Labeling) for Variation files
• Assessment of the workload involved in updating the files affected by the modification requested by the Variation/Clinical/Pharmacovigilance/CMC departments.
• Updating Product Information based on the data provided, validation by the relevant department(s): Clinical or Pharmacovigilance or CMC, integration of comments made previously by other authorities, integration of potential corrections listed in Labeling Follow-up, updating of certain data (European Pharmacopoeia, ICRP, EANM, Guidelines, etc.).
• Adaptation to European or national template: QRD template (Centralized or MRP); Radiopharmaceutical Core SPC, national template (France, UK, etc.).
• Management and monitoring of translations into the relevant languages
• Compilation of the variation file.
• Preparation of documentation related to the variation for the Export zone.
• Responding to scientific/labeling questions following the submission of dossiers.
• Electronic archiving of labeling approvals
• Opening and monitoring of change controls related to labeling activities
• Regulatory watch
Essential Functions
Compilation of five-year renewal files
• Assessment of the workload involved in compiling the file for the country concerned in order to submit it on time.
• Consultation of the national regulations in force.
• Preparation of the Five-Year Renewal dossier, in collaboration with Pharmacovigilance and the Clinical Department, in accordance with the national regulations of the country concerned.
• Compilation of the necessary information in the case of preparation in collaboration with a Consultant (Germany, Austria, Italy, etc.).
• Submission of the file to the authorities directly or via the subsidiary or Consultant.
• Responding to questions following the submission of the file.
New Marketing Authorisations
• Writing product information for new marketing authorization applications in collaboration with the relevant Clinical/Pharmacovigilance/CMC departments.
• Updating of product information: integration of questions/answers from the Agencies during the registration procedure.
• Management and monitoring of readability tests
• Management and monitoring of translations into the relevant languages during the registration process.
• Management of the national phase with the various countries concerned.
Marketing Authorisations Maintenance:
• Responses to requests from authorities, internal departments, or subsidiaries/distributors
• Creation of standard letters in accordance with national regulations: notification of first marketing, revocation of marketing authorization, etc.
• Drafting and updating of Regulatory Affairs procedures
• Regulatory watch
Publishing and tracking of submissions
• Electronic compilation of "publishing" files using the software in force to merge Word, PDF, or other files constituting a Five-Year Renewal or supplementary information file to ultimately obtain one or more volumes of files in electronic format with table of contents, pagination, header/footer, bookmarks, hyperlinks, etc.
• Formatting files in eCTD format in accordance with European and national requirements for electronic submissions
• Management of submission logistics: sending files to all countries, directly to agencies or via subsidiaries or distributors
• Monitoring of submission procedures
• Regulatory watch
Requirements
General knowledge or degree:
o Pharmacy degree or five years of higher education in science/biology
o Specialization in Regulatory Affairs (Master's degree) or at least 5 years' experience in Regulatory Affairs
Specific knowledge:
o Knowledge of marketing authorization applications, registration procedures, renewals and variations in Europe, product information
o Knowledge of pharmaceutical regulations (European Guidelines, EU QRD Templates, CoreSPC, etc.)
o Knowledge of publishing (eCTD files)
o Knowledge of chemistry, biology, and galenics
o Proficiency in office software (Word, Excel, PowerPoint, Adobe Acrobat, Teams, SharePoint)
o Good writing skills
Practical knowledge of the company:
o Knowledge of how the company operates, its organization, and key contacts in Pharmacovigilance, Medical Affairs, CMC, Quality Assurance, Supply Chain, and Marketing
o Interpersonal skills and ability to work in a team
o Analytical and synthesis skills, rigor, and ability to work independently